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AggRecetin 1.0-1.5 mg/mL

by Bio/Data Corporation

Ref 100970

AggRecetin 1.0-1.5 mg/mL (100970) is a device classified as Class A in the EU and Class II in the US made by Bio/Data Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI ++G0561009704A) and listed in FDA GUDID since 23 Mar 2022 (UDI-DI *+G0561009700/ $$042603600562M*), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G0561009704A Basic UDI-DI *+G0561009700/ $$042603600562M*UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561009700/ $$042603600562M* UDI-DI Date23 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++G0561009704A registered 27 May 2026 Active
  • FDA GUDID UDI-DI *+G0561009700/ $$042603600562M* listed 23 Mar 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID *+G0561009700/ $$042603600562M*
  2. Registered EUDAMED ++G0561009704A

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
AggRecetin Reagent EUDAMED
AggRecetin GUDID
Generic name
Platelet aggregation study IVD, reagent
Device name
AggRecetin Reagent (Ristocetin A Sulfate)
Model / Ref / Catalog
100970, 1.0-1.5 mg/mL
Primary DI / UDI-DI
*+G0561009700/ $$042603600562M* EUDAMED
G0561009700 GUDID
Basic UDI-DI
++G0561009704A
FDA product code
JOZ
EMDN code
W01030199 Haematology reagents - other
GMDN term
Platelet aggregation study IVD, reagent
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5700
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
100970
GUDID
1.0-1.5 mg/mL
Primary DI / UDI-DIEUDAMED
*+G0561009700/ $$042603600562M*
GUDID
G0561009700
Device classEUDAMED
Class A
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561009700/ $$042603600562M*; FDA GUDID lists G0561009700), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Platelet aggregation study IVD, reagent

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

Other devices from Bio/Data Corporation

See all devices from Bio/Data Corporation →

Properties

  • Single use
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)